CaboPoint: Interim results from a phase 2 study of cabozantinib after checkpoint inhibitor (CPI) therapy in patients with advanced renal cell carcinoma (RCC).

Authors

Laurence Albiges

Laurence Albiges

Medical Oncology, Gustave Roussy, Université Paris Saclay, Paris, France

Laurence Albiges , Thomas Powles , Anand Sharma , Balaji Venugopal , Jens Bedke , Pascale Dutailly , Bryan Qvick , Lidia Martin-Couce , Valérie Perrot , Viktor Grünwald

Organizations

Medical Oncology, Gustave Roussy, Université Paris Saclay, Paris, France, Barts Cancer Centre, London, UK; The Royal Free London NHS Foundation Trust, London, United Kingdom, Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust, Middlesex, United Kingdom, Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, United Kingdom, Department of Urology, Eberhard-Karls University Tübingen, Tübingen, Germany, Ipsen Pharma, Boulogne-Billancourt, France, Ipsen Pharma GmbH, Munich, Germany, Ipsen Pharma, Barcelona, Spain, Ipsen, Boulogne-Billancourt, France, Essen University Hospital, West German Cancer Center, Clinic for Medical Oncology & Clinic for Urology, Essen, Germany

Research Funding

Pharmaceutical/Biotech Company
Ipsen

Background: First line CPI-based therapy is the standard of care for advanced RCC. There is a lack of prospective data for cabozantinib after 1L CPI regimens, which is addressed in this study. Methods: CaboPoint (ClinicalTrials.gov identifier: NCT03945773) is an ongoing Phase 2, multicenter, open-label study of cabozantinib in adults with unresectable, locally advanced, or metastatic clear cell RCC who have progressed after 1L CPI-based therapy. Prior treatment with cabozantinib was not permitted. Patients received cabozantinib in two independent cohorts (cohort A [post nivolumab + ipilimumab] and cohort B [post CPI + vascular endothelial growth factor targeted therapy]). Both cohorts received cabozantinib (60 mg/day as starting dose) until study end (18 months after last patient’s enrollment). The primary endpoint was objective response rate (ORR) in Cohort A per RECIST 1.1 evaluated by independent central review; ORR by investigator review has been included as a secondary endpoint for both cohorts. Here we report results from the pre-planned interim analysis of ORR based on investigator assessment in both cohorts that occurred when 80% of patients in cohort A reached at least 3 months of treatment. Results: At the time of this interim analysis, 88 patients had 3 months of follow up (60 in cohort A and 28 in cohort B). Baseline characteristics were similar across cohorts. Patients had an Eastern Cooperative Oncology Group status of 0 (55.0% / 60.7%) and an intermediate or poor International Metastatic RCC Database Consortium risk (46.3% and 13.0% / 40.7% and 11.1%). The most common prior treatment in cohort B was pembrolizumab + axitinib (71.4%), followed by avelumab + axitinib (28.6%). ORR and best overall response at three months of follow-up as assessed by the Investigator are shown in the table. Conclusions: In this interim analysis, cabozantinib demonstrated preliminary efficacy in patients with advanced RCC after progression on CPI-based combination therapy, irrespective of 1L regimen. The CaboPoint trial is ongoing, with the final analysis anticipated in September 2023. Clinical trial information: NCT03945773.

Cohort A
(n = 60)
Cohort B
(n = 28)
Overall
(N = 88)
ORR (95% CI), %31.7 (20.3–45.0)a25.0 (10.7–44.9)a29.5 (20.3–40.2)a
Best overall responsen = 57n = 25N = 82
Complete Response, %04.01.2
Partial Response, %33.324.030.5
Stable Disease, %50.952.051.2
Progressive Disease, %15.820.017.1

aInvestigator-assessed ORR was calculated based on the number of patients in each analysis population (cohort A, n = 60; cohort B, n = 28).

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Abstract Session: Renal Cell Cancer and Rare Tumors

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT03945773

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 606)

DOI

10.1200/JCO.2023.41.6_suppl.606

Abstract #

606

Abstract Disclosures